Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation

Franck Morschhauser, Tim Illidge, Damien Huglo, Giovanni Martinelli, Giovanni Paganelli, Pier Luigi Zinzani, Simon Rule, Anna Marina Liberati, Noel Milpied, Georg Hess, Harald Stein, Joachim Kalmus, Robert Marcus

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Abstract

A prospective, multicenter, nonrandomized phase 2 trial was conducted to evaluate the efficacy and safety of a single dose of yttrium-90 (90Y) ibritumomab tiuxetan in elderly patients in first relapsed or primary refractory diffuse large B-cell lymphoma (DLBCL) ineligible for stem-cell transplantation. Patients had been previously treated with chemotherapy (group A, n = 76) or chemotherapy plus rituximab (group B, n = 28). Patients in group A were further divided into patients in whom induction therapy had failed (stratum AI, n = 33) and patients who had relapsed after achieving complete response (CR; stratum AII, n = 43). The overall response rate (ORR) was 52% and 53% in strata AI and AII, respectively, and 19% in group B, with CR/CRu rates of 24%, 39.5%, and 12%, respectively. Median progression-free survival was 5.9 months and 3.5 months in strata AI and AII, respectively, and 1.6 months in group B. Median overall survival was 21.4, 22.4, and 4.6 months in stratum AI, stratum AII, and group B, respectively. Two patients died from thrombocytopenic cerebral bleeding following administration of therapy. Nonhematologic adverse events were mild to moderate. 90Y-ibritumomab is active in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) and its further evaluation in phase 3 studies is ongoing.

Original languageEnglish
Pages (from-to)54-58
Number of pages5
JournalBlood
Volume110
Issue number1
DOIs
Publication statusPublished - Jul 1 2007

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Chemotherapy
Lymphoma, Large B-Cell, Diffuse
Stem Cell Transplantation
Stem cells
Refractory materials
Cells
Safety
Yttrium
Drug Therapy
ibritumomab tiuxetan
Disease-Free Survival
Hemorrhage
Survival
Therapeutics
Rituximab

ASJC Scopus subject areas

  • Hematology

Cite this

Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation. / Morschhauser, Franck; Illidge, Tim; Huglo, Damien; Martinelli, Giovanni; Paganelli, Giovanni; Zinzani, Pier Luigi; Rule, Simon; Liberati, Anna Marina; Milpied, Noel; Hess, Georg; Stein, Harald; Kalmus, Joachim; Marcus, Robert.

In: Blood, Vol. 110, No. 1, 01.07.2007, p. 54-58.

Research output: Contribution to journalArticle

Morschhauser, F, Illidge, T, Huglo, D, Martinelli, G, Paganelli, G, Zinzani, PL, Rule, S, Liberati, AM, Milpied, N, Hess, G, Stein, H, Kalmus, J & Marcus, R 2007, 'Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation', Blood, vol. 110, no. 1, pp. 54-58. https://doi.org/10.1182/blood-2007-01-068056
Morschhauser, Franck ; Illidge, Tim ; Huglo, Damien ; Martinelli, Giovanni ; Paganelli, Giovanni ; Zinzani, Pier Luigi ; Rule, Simon ; Liberati, Anna Marina ; Milpied, Noel ; Hess, Georg ; Stein, Harald ; Kalmus, Joachim ; Marcus, Robert. / Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation. In: Blood. 2007 ; Vol. 110, No. 1. pp. 54-58.
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abstract = "A prospective, multicenter, nonrandomized phase 2 trial was conducted to evaluate the efficacy and safety of a single dose of yttrium-90 (90Y) ibritumomab tiuxetan in elderly patients in first relapsed or primary refractory diffuse large B-cell lymphoma (DLBCL) ineligible for stem-cell transplantation. Patients had been previously treated with chemotherapy (group A, n = 76) or chemotherapy plus rituximab (group B, n = 28). Patients in group A were further divided into patients in whom induction therapy had failed (stratum AI, n = 33) and patients who had relapsed after achieving complete response (CR; stratum AII, n = 43). The overall response rate (ORR) was 52{\%} and 53{\%} in strata AI and AII, respectively, and 19{\%} in group B, with CR/CRu rates of 24{\%}, 39.5{\%}, and 12{\%}, respectively. Median progression-free survival was 5.9 months and 3.5 months in strata AI and AII, respectively, and 1.6 months in group B. Median overall survival was 21.4, 22.4, and 4.6 months in stratum AI, stratum AII, and group B, respectively. Two patients died from thrombocytopenic cerebral bleeding following administration of therapy. Nonhematologic adverse events were mild to moderate. 90Y-ibritumomab is active in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) and its further evaluation in phase 3 studies is ongoing.",
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AU - Huglo, Damien

AU - Martinelli, Giovanni

AU - Paganelli, Giovanni

AU - Zinzani, Pier Luigi

AU - Rule, Simon

AU - Liberati, Anna Marina

AU - Milpied, Noel

AU - Hess, Georg

AU - Stein, Harald

AU - Kalmus, Joachim

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